vaccine therapy in treating patients who are undergoing surgery for stage ib, stage ii, or stage iiia non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: vaccines made from a person's tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells. purpose: this phase i trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage ib, stage ii, or stage iiia non-small cell lung cancer.

objectives: primary * determine the maximum tolerated dose of adjuvant autologous dendritic cells loaded with irradiated autologous tumor cells in patients with stage ib-iiia non-small cell lung cancer undergoing resection. * determine the safety and tolerability of this vaccine in these patients. secondary * determine the feasibility of this vaccine in these patients. * determine vaccine-specific and antitumor immunity in patients treated with this vaccine. outline: this is a dose-escalation study. patients undergo leukaphersis to isolate peripheral blood mononuclear cells (pbmc). pbmc are expanded ex vivo to generate monocyte-derived dendritic cells (dc). autologous tumor cells are harvested and purified at the time of surgical resection. dc are then loaded with irradiated autologous tumor cells. within 4-8 weeks after surgical resection, patients receive autologous dc loaded with irradiated autologous tumor cells intradermally on approximately days 1, 30, and 60 in the absence of unacceptable toxicity. cohorts of 6-9 patients receive escalating doses of vaccine until the maximum tolerated dose (mtd) is determined. if 2 of 9 patients in the first cohort experience dose-limiting toxicity, that dose level is considered the mtd. patients are followed at approximately 1 and 4 months, and then every 6 months for 4 years. projected accrual: a total of 12-15 patients will be accrued for this study within 18 months.

Eligibility criteria:
disease characteristics: * diagnosis of non-small cell lung cancer * clinical stage ib-iiia disease * candidate for surgical resection as primary treatment for tumor * surgically resectable tumor ≥ 2.0 cm in diameter * no brain metastases patient characteristics: age * 18 and over performance status * zubrod 0-1 life expectancy * not specified hematopoietic * platelet count ≥ 100,000/mm\^3 * wbc ≥ 3,000/mm\^3 * absolute neutrophil count ≥ 1,500/mm\^3 * hematocrit ≥ 30% hepatic * hepatitis b surface antigen negative\* * hepatitis b core antigen negative\* * hepatitis c virus negative\* * bilirubin ≤ 2.0 mg/dl * ast and alt ≤ 2 times upper limit of normal note: \*screening performed only if liver enzymes are elevated renal * creatinine ≤ 2.2 mg/dl * bun ≤ 40 mg/dl pulmonary * fev_1 \> 2.0 l (pre-resection) or * predicted post-resection fev_1 \> 1.0 l * no more than 2 chronic obstructive pulmonary disease exacerbations requiring \> 2 weeks of oral steroids and/or hospitalization within the past year immunologic * purified protein derivative (ppd) skin test negative * hiv-1 and hiv-2 negative * no acute infection, including any acute viral, bacterial, or fungal infection requiring specific therapy within the past 7 days * no allergy to study agents * no known autoimmune or collagen vascular disorder other * not pregnant or nursing * fertile patients must use effective contraception * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * no underlying condition that would preclude study therapy prior concurrent therapy: biologic therapy * no concurrent anti-tumor necrosis factor agents chemotherapy * standard adjuvant chemotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine * no concurrent cyclophosphamide endocrine therapy * no concurrent high-dose corticosteroids (e.g., \> 10 mg of prednisone) * concurrent corticosteroids for minor breathing exacerbations allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period * no concurrent corticosteroids within 48 hours before or after study vaccine administration radiotherapy * standard adjuvant radiotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine surgery * no prior organ allograft other * no concurrent antihistamines within 48 hours before or after study vaccine administration * no concurrent cimetidine or other h2 blockers within 48 hours before or after study vaccine administration * concurrent antibiotics for minor infection allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period * no concurrent cyclosporine * no concurrent azathioprine * no other concurrent drugs known to significantly alter immune function * no concurrent cytotoxic therapy * no concurrent participation in another clinical trial involving experimental therapy * no other concurrent anticancer therapy

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer